MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age25-50
SponsorAustin V Stone
About this trial
This is a multicenter randomized, placebo-controlled trial to assess whether a 6-month course of oral montelukast after ACL reconstruction reduces systemic markers of inflammation and biochemical and imaging biomarkers of cartilage degradation. This study will specifically target older ACL reconstruction patients with concomitant meniscal injuries as this group is at greatest risk of rapid PTOA progression. Patients will randomly be assigned to receive oral montelukast (10 mg) versus placebo daily for 6 months after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergoing primary ACL reconstruction
Age between 25-50
Concomitant meniscus injury
Disqualifiers
Undergoing revision procedures
Multiple ligament injuries requiring multiple ligament reconstruction/repair
Depressive symptoms and/or those who endorse suicidal ideation at the time of enrollment (PHQ-9 score >= 15)
Found to not have a meniscus tear at the time of surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Montelukast
DrugThe novel use of oral montelukast offers the potential of a disease modifying treatment to prevent irreversible cartilage loss after ACL injury. 10mg of oral Montelukast will be taken daily for 6 months post surgery.
Placebo
DrugAn oral placebo will be taken daily for 6 months post surgery.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: MontelukastExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Serum prostaglandin E2
Prostaglandin E2 is a potential inflammatory mediator, and it is being measured to directly assess whether treatment reduces this systemic inflammatory marker. Greater serum prostaglandin is associated with greater inflammation.
Time frame
Change between Visit 3 (10 days post surgery) and Visit 6 (1 year post surgery)2
T1rho relaxation time on MRI
T1rho relaxation time is a validated measure of proteoglycan content within the cartilage, and can be assessed on MRI. Increased T1rho relaxation time is associated with increased cartilage degeneration.
Time frame
Change between Visit 4 (4 weeks post surgery) and Visit 6 (1 year post surgery)3
Shape of the medial femoral condyle on MRI
The shape of the medial femoral condyle has been previously demonstrated to change after ACL reconstruction and is predictive of later cartilage changes. Flattening and widening of the medial femoral condyle are considered to be indicative of later cartilage changes.
Time frame
Change between Visit 4 (4 weeks post surgery) and Visit 6 (1 year post surgery)4
Knee injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome instrument that is comprised of 5 subscales (Pain, Symptoms, Activities of Daily Living, Sports and Recreation, and Quality of Life) with each scale being scored from 0 to 100 with higher scores being indicative of a superior outcome.
Time frame
Change between Visit 3 (10 days post surgery) and Visit 6 (1 year post surgery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Austin V Stone
Lead sponsor
University of Kentucky
Sponsor institution
Duke University
Collaborator
The Cleveland Clinic
Collaborator
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov